A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction

A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Two Dose Combinations of Metyrapone and Oxazepam in the Treatment of Cocaine Addiction

Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks. The study will include twice weekly visits to the research clinic for laboratory studies, safety assessments and urine drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.

Study Overview

• Status: Completed
• Conditions: Cocaine Dependence; Cocaine Addiction
• Intervention / Treatment: Drug: Placebo; Drug: Metyrapone; Drug: Oxazepam

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Department of Psychiatry, Psychopharmacology Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, 18 - 50 years of age
• Requests treatment for cocaine addiction
• Meets the DSM-IV criteria for cocaine dependency
• Able to provide written informed consent and comply with the study
• Females of childbearing potential must have a negative pregnancy test and must be using adequate birth control during the study
• Test positive for cocaine on a urinary drug screen
• Healthy and medically stable in the opinion of the Principal Investigator

Exclusion Criteria:

• Liver enzymes greater than two times normal
• Any history of hepatitis
• History of disorders requiring chronic treatment with steroids
• Significantly abnormal ECG
• Any prominent DSM-IV axis I disorders other than cocaine dependence
• Any subject who presents as a danger to self or others in the opinion of the Principal Investigator
• Concomitant use of methamphetamine as determined by self-reporting and verified by measurement of methamphetamine in urinary drug screen
• Alcohol consumption greater than 4 drinks per day (1 Drink = 12 oz beer; 5 oz wine; 1.5 oz shot of liquor)
• Any clinically significant laboratory test abnormalities
• Use of any concomitant medication during the study that would interfere with study medications
• Serum cortisol less than 3 µg/dl at any time before or during study
• Treatment with an investigational product within 30 days prior to study enrollment
• Currently seeking other forms of professional addiction treatment
• Known allergic reaction to oxazepam or metyrapone
• Lactose intolerance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Twice daily
Active Comparator: Metyrapone 500 mg oxazepam 20 mg; Lower dose combination of metyrapone with oxazepam, total daily dose	Drug: Metyrapone; Twice daily; Other Names: Metopirone; Drug: Oxazepam; Twice Daily; Other Names: Serax
Active Comparator: Metyrapone 1500 mg oxazepam 20 mg; Higher dose combination of metyrapone with oxazepam, total daily dose	Drug: Metyrapone; Twice daily; Other Names: Metopirone; Drug: Oxazepam; Twice Daily; Other Names: Serax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cocaine Craving Questionnaire Brief	The Cocaine Craving Questionnaire Brief (CCQ-Brief) is an abbreviated version of the CCQ-Now that includes ten items (CCQ-Now includes 45 items). The scale measures cocaine craving symptoms. The 10 items are scored on a one to seven scale with 8 positively-keyed items and two negatively-keyed items. The score is the sum of the individual items divided by 10 (lowest possible score, indicating lowest level of cocaine craving) is 1 and highest possible total score (indicating the highest level of cocaine craving, is 10). There are no subscores.	Week 1, Day 3 to Week 6, day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology	6 weeks
Improvement in anxiety and depression symptoms	6 weeks

Collaborators and Investigators

• Sponsor: Embera NeuroTherapeutics, Inc.
• Investigators: Principal Investigator: Anita S Kablinger, MD, LSU Health Sciences Center - Shreveport

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: December 3, 2007
• First Submitted That Met QC Criteria: December 3, 2007
• First Posted (Estimated): December 5, 2007

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Dependence; Cortisol; Addiction; Cocaine; GABA
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Behavior, Addictive; Cocaine-Related Disorders; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Benzodiazepines; Benzodiazepinones; Metyrapone; Oxazepam
• Other Study ID Numbers: ECA-001